רדאר קליני AI | ||
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הניסוי הקליני NCT02734667 עבור סוכרת נעורים סוג 1 הוא הושלם. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes 120
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT02734667 היה מחקר מסוג התערבותי עבור סוכרת נעורים סוג 1, שכעת הושלם. המחקר התחיל ב-1 בפברואר 2016 ותוכנן לכלול 120 משתתפים. המחקר נוהל על ידי Korey Hood ותאריך הסיום היה 1 בפברואר 2020. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-2 במרץ 2022.
סיכום קצר
The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.
תיאור מפורט
Synopsis of study protocol
This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control group). The investigators will examine group differences over a 6-month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial comparison of intervention to control across the first ...
הצג עודכותרת רשמית
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
מצבים רפואיים
סוכרת נעורים סוג 1מזהי מחקר נוספים
- 35990
מספר NCT
תחילת המחקר (בפועל)
2016-02
עדכון אחרון שפורסם
2022-03-02
סיום המחקר (מוערך)
2020-02
משתתפים (מתוכנן)
120
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
הושלם
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיCGM at diagnosis of T1D Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months. | CGM at diagnosis of T1D Initiation of non-adjunctive CGM use at diagnosis of T1D |
ללא טיפולUsual Care Participants receive usual care for T1D for 6 months post diagnosis. | לא ישים |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Time Spent in Blood Glucose Range (70-180mg/dL) | Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point. | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point |
Glucose Monitoring Satisfaction Survey (GMSS) - Parent | The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction. | Baseline, 24 months |
Time Spent in Hypoglycemia (< 70 mg/dL) | Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point. | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Pediatric Quality of Life Inventory | This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life. | Baseline, 24 months |
Problem Areas in Diabetes Score | Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems. | Baseline, 24 months |
Diabetes Distress Scale | This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress. | Baseline, 24 months |
Patient Health Questionnaire 9 | This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms. | Baseline, 24 months |
State-Trait Anxiety Inventory | This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety. | Baseline, 24 months |
Pittsburgh Sleep Quality Index | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality. | Baseline, 24 months |
Hypoglycemic Fear Survey | People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia. | Baseline, 24 months |
Hypoglycemic Confidence Questionnaire | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia. | Baseline, 24 months |
General and Diabetes-specific Technology Use | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology. | Baseline, 24 months |
Center for Epidemiologic Studies Depression Measure | This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms. | Baseline, 24 months |
Child Health Utility 9D | Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented. | Baseline, 24 months |
Hemoglobin A1c | The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample. | Baseline, 24 months |
C-peptide | This is a biologic measure of endogenous production and is collected through a blood sample. | Baseline, 24 months |
קריטריוני זכאות
גילאים מוערכים למחקר
ילד
גיל מינימלי למחקר
2 Years
מגדרים מוערכים למחקר
הכל
To be eligible for the study, a child must meet the following criteria:
- Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- Time since diagnosis of no longer than one month
- Age between 2 and 17 years
- Parental consent (and assent from the child where applicable) to participate in the study
- No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
To be eligible for the study, a parent must meet the following criteria:
- Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- Age of 18.0 years or older
- Parent comprehends written English
- Parent understands the study protocol and signs the informed consent document
The presence of any of the following is an exclusion for the study:
- Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Child is unable to completely avoid acetaminophen for duration of study
Korey Hoodאוניברסיטת קולורדו בדנבר480 מחקרים פעילים לחקורהגורם האחראי למחקר
Korey Hood, חוקר נותן החסות, Clinical Professor, Stanford University
אין נתוני קשר.
2 מיקומי המחקר ב-1 מדינות
California
Stanford University, Stanford, California, 94305, United States
Colorado
University of Colorado, Aurora, Colorado, 80045, United States